Senior Production Engineer – Medical Devices (Lean/GMP)

Beta Bionics, Inc.; Irvine (CA); On-site; USD 95,000 - 130,000; Full time

Benefits offered by this job

Comprehensive medical and dental

FSA and HSA plan options

401(k) with employer match

Generous vacation accrual

Job summary

Beta Bionics, Inc. in Irvine, CA, seeks a Senior Production Engineer to design, develop and implement manufacturing processes that meet product specifications, stay cost-efficient, safe, and compliant with quality standards.

You will monitor process performance, drive improvements, and coordinate with engineering, quality, maintenance and supply chain to achieve production goals; some travel and extended hours may be required.

Qualifications

• Bachelor’s degree in Mechanical, Manufacturing, Industrial, or Biomedical Engineering.
• 5–8 years in a medical device environment.
• Experience with FDA/GMP/ISO compliance.
• Ability to read mechanical drawings and electrical schematics.
• Proficient with Microsoft Office and related software.

Responsibilities

• Design, develop and implement manufacturing processes and procedures.
• Ensure compliance with quality standards and regulatory requirements.
• Monitor KPIs (yield, scrap, downtime, cycle time) and take corrective actions.
• Develop process improvements to maximize equipment utilization.
• Coordinate with engineering, quality, maintenance and supply chain.
• Troubleshoot and resolve technical issues with machinery or software.
• Communicate with customers and suppliers to ensure satisfaction.

Skills

QSRs/GMPs knowledge

Hand tools

Mechanical drawings & schematics

Microsoft Office

Cross-functional collaboration

Problem solving

Education

Bachelor’s Degree in Mechanical/Manufacturing/Industrial/Biomedical Engineering

Tools

Drills

Soldering irons

Micrometers

Calipers

Job description

Beta Bionics, Inc. in Irvine, CA, seeks a Senior Production Engineer to design, develop and implement manufacturing processes that meet product specifications, stay cost-efficient, safe, and compliant with quality standards.

You will monitor process performance, drive improvements, and coordinate with engineering, quality, maintenance and supply chain to achieve production goals; some travel and extended hours may be required.